FDA approves Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma

MorphoSys

31 July 2020 - First FDA approval of a second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma, helping fill a high unmet medical need.

MorphoSys and Incyte today announced that the U.S. FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.

Read MorphoSys press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US